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Senior Design Assurance Engineer

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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Job Summary

Provide design assurance support for new product development and on market medical devices.  This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.

Essential Duties

Duties are listed in order of greatest importance.  The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  • Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.  Test method validation would be an element of assuring verification/validation is acceptable.
  • Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
  • Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
  • Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
  • Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

Qualifications

Education  

  • Technical Bachelor Degree

Experience 

  • 2-5 years’ experience preferably in medical device industry

Skills

  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
  • Experienced with ISO 14970, Risk Management
  • Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.
  • Working knowledge of verification and validation requirements for a regulated product
  • Working knowledge of requirements analysis, including development of testable and measurable specifications
  • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
  • Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment
  • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments strongly preferred

Organizational Relationships

  • Works with Divisional and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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